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United States · US · US:70518-3237_4b04e14b-81c3-42d7-e063-6394a90aaeaa

Oxcarbazepine

Orange BookUNIISPLATC N03AF02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN03AF02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051832372
    30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3237-2)

Annotations

UNII (FDA Substance ID)
VZI5B1W380
OXCARBAZEPINE
RxCUI 32624
Orange Book
A077802
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "VZI5B1W380",
    "rxcui": "32624",
    "inchikey": "CTRLABGOLIVAIY-UHFFFAOYSA-N",
    "display_name": "OXCARBAZEPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a18f591b-587e-4769-8ac2-9cfba0b82526": {
      "match": "brand_token",
      "title": "OXCARBAZEPINE (OXCARBAZEPINE) SUSPENSION [CAMBER PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2026-05-25"
    }
  },
  "productid": "70518-3237_4b04e14b-81c3-42d7-e063-6394a90aaeaa",
  "productndc": "70518-3237",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077802",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Oct 9, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Oct 9, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "003",
        "approval_date": "Oct 9, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXCARBAZEPINE",
  "proprietary_name": "Oxcarbazepine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077802",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Oxcarbazepine",
  "start_marketing_date": "20211013",
  "active_numerator_strength": "300"
}

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